Zanubrutinib 80mg/d
DrugZanubrutinib: 80 mg taken orally once daily for 26 weeks
NCT Number: NCT07315373
The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zanubrutinib: 80 mg taken orally once daily for 26 weeks
Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.
Zanubrutinib: 160 mg taken orally once daily for 26 weeks
Zanubrutinib: 240 mg taken orally once daily for 26 weeks
Time frame: 26 weeks
The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 26-week follow-up.
Time frame: day 14
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Time frame: day 14
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
Time frame: 6 month
The time from starting treatment to time of achievement of CR or R
Time frame: 26 weeks
Duration of response at 26-week follow up
Time frame: 26 weeks
Number of patients with bleeding
Time frame: 26 weeks
Number of patients with adverse events
Time frame: 26 weeks
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Time frame: baseline and 26 weeks
Health-related quality of life using the Immune Thrombocytopenic Purpura-Patient Assessment Questionnaire (ITP-PAQ)
Contact information is provided by the study sponsor or research team.
Qiusha Huang, MD
CONTACT
Xiaohui Zhang, MD
CONTACT
Peking University People's Hospital
Other
The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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